SBRT + Surgical Stabilization for Bone Metastases

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byMaksim Vaynrub, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.

Eligibility Criteria

This trial is for adults over 18 with cancer that has spread to their bones, who are at risk of bone fractures due to the disease. They must be able to undergo surgery, give informed consent, use effective birth control if needed, and have a life expectancy over 3 months. Excluded are those with prior treatments or surgeries in the affected area, high skin dose risks from radiation, immediate fracture risks, certain autoimmune diseases, active infections or low neutrophil counts.

Inclusion Criteria

I can give consent myself or through a legal representative if I'm unable to make decisions.

Life expectancy >3 months

I can undergo radiation treatment without moving the affected body part.

+5 more

Exclusion Criteria

My tumor cannot be effectively treated with focused radiation due to its size or spread.

The skin at my surgery area is expected to receive a high dose of radiation.

I have had surgery on the area being considered for the trial.

+8 more

Participant Groups

The study tests the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) followed by surgical stabilization within one week on patients with bone metastases. The goal is to see if this treatment prevents cancer from returning to the treated bone area.

1Treatment groups

Experimental Treatment

Group I: Preoperative Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention

Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction. Active sparing of the intended surgical approach will be incorporated into the radiation plan by creating an avoidance structure. Surgical stabilization will proceed within 1 week of completion of radiotherapy. Pathologic specimens will be obtained intraoperatively via existing surgical access for histologic and molecular analysis. An optional research MRI with perfusion will be performed within 30 days prior to radiation simulation and within one-week after radiation therapy using 3T scanner. If patients receive radiation simulation at a non-MSK Manhattan site, MRI with Perfusion will not be performed.